Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to find the best monthly dose schedule for the new Hepatitis Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent Lamivudine after liver transplantation. Boca HBVIg will be given along with Lamivudine to prevent hepatitis B reinfection following liver transplantation in patients with end stage liver failure due to hepatitis B infection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis B Immune Globulin (Boca HBVIg) | Biological | Phase I (12 weeks): Intravenous Boca HBVIg 10,000 IU administered intraoperatively during the anhepatic phase, following reperfusion, daily on days 1-7, once during week 4 and once during week 8 (total of 11 doses). Phase II (24 weeks): Starting at 12 weeks post liver transplantation, Boca HBVIg will be reduced to 5,000 IU given intravenously on a monthly basis for patients who had an anti-HBs trough titer greater than or equal to 500 IU/L at 8 weeks without the need for additional Boca HBVIg doses. Patients with an 8 week trough level less than 500 IU/L will receive 10,000 IU Boca HBVIg every 4 weeks for the remainder of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of hepatitis B virus positive liver transplant recipients with no hepatitis B virus recurrence after liver transplantation. | ||
| Number of participants who maintain a protective trough titer of anti hepatitis B antibodies beginning at 12 weeks post liver transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anti hepatitis B antibodies levels with administration of Boca hepatitis B immune globulin concomitantly with Lamivudine. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rolland C. Dickson, M.D. | Mayo Clinic | Principal Investigator |
| Norah A. Terrault, M.D., MPH | University of California, San Francisco, CA | Principal Investigator |
| Donald Jensen, M.D. | Rush-Presbyterian - St. Luke's Medical Center, Chicago, IL | Principal Investigator |
| Terence Angtuaco, M.D. | Rush-Presbyterian - St. Luke's Medical Center, Chicago, IL | Principal Investigator |
| Patricia Sheiner, M.D. | Mount Sinai Medical Center, New York, NY | Principal Investigator |
| Velimir A. Luketic, M.D. | Virginia Commonwealth University, Richmond, VA | Principal Investigator |
| Michael Fried, M.D. | University of North Carolina, Chapel Hill, NC | Principal Investigator |
| Robert S. Brown, M.D., MPH | Columbia-Presbyterian Medical Center, New York, NY | Principal Investigator |
| Michael Ishitani, M.D. | Rochester Methodist Hospital, Rochester, MN |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| University of Florida |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Principal Investigator |
| Consuelo Soldevila-Pico, M.D. | University of Florida | Principal Investigator |
| Anna Lok, M.D. | University of Michigan, Ann Arbor, MI | Principal Investigator |
| Rajender Reddy, M.D. | University of Miami, Miami, FL | Principal Investigator |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Jackson Memorial Hospital / University of Miami | Miami | Florida | 33136 | United States |
| Rush-Presbyterian - St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| The University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Rochester Methodist Hospital | Rochester | Minnesota | 55905 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| New York-Presbyterian Hospital Columbia-Presbyterian Medical Center | New York | New York | 10032 | United States |
| The University of North Carolina Hospitals | Chapel Hill | North Carolina | 27599 | United States |
| Medical College of Virginia Commenwealth University | Richmond | Virginia | 23298 | United States |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
Not provided
Not provided
| ID | Term |
|---|---|
| C045213 | hepatitis B hyperimmune globulin |
Not provided
Not provided
Not provided